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AMARIN CORP PLC\UK (AMRN)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 revenue was $42.0M, down 26% year over year and below S&P consensus of $50.7M; diluted EPS was a loss of $0.04, materially better than the S&P consensus loss of $0.77, reflecting stronger-than-expected bottom-line containment despite top-line pressure [- $50.7M*, -$0.77*].
  • Gross margin improved to 59% vs. 55% in Q1 2024 on customer mix, while operating expenses fell 8% YoY; net loss widened to $15.7M as U.S. price/volume declines persisted amid generics .
  • Europe recorded $5.4M in product revenue with in‑market demand up 16% sequentially; Italy access reached 14 of 21 regions (~85% of eligible patients), and Austria added national reimbursement, extending momentum for 2025 .
  • Liquidity remained strong with $281.8M in cash and investments and no debt; company regained Nasdaq compliance after completing a 1‑for‑20 ADS ratio change, removing a listing overhang .

Values retrieved from S&P Global for estimate metrics marked with *.

What Went Well and What Went Wrong

What Went Well

  • Europe momentum: in‑market demand for VAZKEPA grew 16% QoQ; Italy access secured in 14/21 regions (~85% of eligible patients), and Austria achieved national reimbursement, with decisions expected in Norway and Ireland later in 2025 .
  • Margin/OpEx discipline: gross margin rose to 59% (from 55% LY) on mix, and total operating expenses decreased 8% YoY to $41.9M (SG&A $36.6M; R&D $5.3M), underscoring prudent cost management .
  • Clear strategic focus: management emphasized profitable U.S. branded execution, accelerating European growth under extended IP to 2039, and early RoW commercialization, citing “continued steady execution” against maximizing VASCEPA/VAZKEPA’s global value .

Selected quote: “Our focus remains clear: capitalize on the significant opportunity in Europe, efficiently generate revenue and strong cash flow in the U.S. and Rest of World markets and tightly manage operating expenses to support our strong balance sheet.” — Aaron Berg, President & CEO .

What Went Wrong

  • Top-line pressure: total net revenue fell to $42.0M (-26% YoY) as U.S. price/volume declined due to generics; U.S product revenue dropped to $35.7M (from $48.1M LY) .
  • RoW variability: RoW product revenue was “< $0.1M” vs. $5.2M LY, driven by early-stage commercialization and shipment timing; management cautioned quarter-to-quarter variability as partners ramp .
  • Bottom-line: GAAP net loss widened to $15.7M (from $10.0M LY), with adjusted non‑GAAP loss at $9.4M; while EPS beat consensus, underlying profitability remains challenged by U.S. generics .

Financial Results

Multi-period actuals (chronological: Q3 2024 → Q4 2024 → Q1 2025)

MetricQ3 2024Q4 2024Q1 2025
Revenue ($USD Millions)$42.3 $62.3 $42.0
Diluted EPS ($)$(0.06) $(0.12) $(0.04)
Gross Margin (%)38% 41% (ex‑inventory restructuring) 59%
Total Operating Expenses ($M)$41.4 $43.0 $41.9

Q1 2025 vs S&P Global consensus

MetricActual Q1 2025Consensus Q1 2025
Revenue ($USD Millions)$42.0 $50.7*
Primary EPS ($)$(0.04) $(0.77)*
# of Estimates (EPS)—2*
# of Estimates (Revenue)—2*

Values retrieved from S&P Global for estimate metrics marked with *.

Segment revenue breakdown (product revenue)

Segment ($USD Millions)Q3 2024Q4 2024Q1 2025
U.S.$30.6 $44.2 $35.7
Europe$4.3 $4.0 $5.4
Rest of World (RoW)$6.9 $11.9 < $0.1

KPIs and non-GAAP

KPIQ3 2024Q4 2024Q1 2025
Cash & Investments ($M)$305.7 $294.2 $281.8
SG&A ($M)$36.9 $37.0 $36.6
R&D ($M)$4.5 $6.0 $5.3
GAAP Net Loss ($M)$(25.1) $(48.6) $(15.7)
Adjusted Net Loss ($M)$(20.4)$(8.7) $(9.4)
Adjusted EPS ($)$(0.05)$(0.02) $(0.02)

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Tariff impact2025Not material (company monitoring) No material impact expected; none observed in Q1 Maintained
U.S. volume seasonality2025CVS shift expected to pressure H1 2025 YoY comps Expect pickup in Q2; possible declines in Q3–Q4 Clarified
Authorized generic (AG)Life-cyclePrepared to launch when advantageous Plan prepared; will introduce when advantageous Maintained
Liquidity/cash runway2025Adequate to support operations for foreseeable future Strong capital structure; $281.8M cash & investments, no debt Maintained
Nasdaq listing2025Plan to initiate ADS ratio change Ratio change completed; compliance regained Achieved

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2024)Previous Mentions (Q4 2024)Current Period (Q1 2025)Trend
Europe commercializationRevenues growing in UK/Spain; IP extended to 2039; push for reimbursement (Greece/Portugal/Italy progress) In‑market demand grew QoQ; Italy national reimbursement; Austria reimbursement; targeting >5M high‑risk patients Demand +16% QoQ; $5.4M revenue; Italy 14/21 regions (~85% eligible); Austria launched April; Norway/Ireland decisions expected Improving
U.S. net price/volume & rebatesGreater generic pressure; maintaining >50% IPE share; rebate pressure rising CVS change to “not covered” impacting H1 2025 comps Profitability maintained; seasonality: Q2 pickup, potential Q3–Q4 declines Mixed; pressured but stable cash
RoW partnershipsEarly launches; Australia PBS listing; China CVRR approval; partners ramping RoW revenue $11.9M; variability due to launch shipments End‑market demand up sequentially; Q1 revenue minimal due to shipment timing; NRDL pursuit in China (2026) Early-stage variability
Regulatory/legalExtended EU IP to 2039 Announced ADS ratio change to maintain Nasdaq Completed ratio change; regained Nasdaq compliance De‑risked listing
R&D / medical advocacy25+ publications YTD; focus on Lp(a), ACS 45 publications in 2024; ACC’25 data on EPA mechanisms; REDUCE‑IT subgroup analyses Ongoing presence; ~100 abstracts since 2023; continued mechanistic evidence; global guideline support Sustained drumbeat

Management Commentary

  • “Our first quarter operational and financial performance reflects continued steady execution against our strategy to maximize the global value of VASCEPA/VAZKEPA…capitalize on the significant opportunity in Europe, efficiently generate revenue and strong cash flow in the U.S. and Rest of World markets and tightly manage operating expenses.” — Aaron Berg, President & CEO .
  • “We are continuing to efficiently generate cash with VASCEPA…retaining all of our major exclusive accounts…we remain prepared to launch our authorized generic when deemed necessary.” — Aaron Berg .
  • “As of March 31, 2025, Amarin has aggregate cash and investments of $282M with no debt…we have kept our cash burn below 10% over the last 10 quarters.” — Peter Fishman, CFO .
  • “VAZKEPA revenues continued gradual growth…$5.4M in the quarter, representing 16% sequential growth…secured access in 14 of 21 regions in Italy (~85% eligible).” — Aaron Berg .
  • “We completed a 1‑for‑20 ADS ratio change…regained compliance with Nasdaq minimum bid price requirement…Nasdaq now considers this matter closed.” — Company press release .

Q&A Highlights

  • RoW revenue variability: Management emphasized early-stage commercialization and shipment timing—quarterly results will be “choppy” even as end‑market demand trends upward across launched geographies .
  • Differentiation and data: Continued real‑world/clinical data generation leveraging REDUCE‑IT, mechanistic EPA evidence, and global guideline endorsements to strengthen positioning vs. generics and emerging cardio‑metabolic therapies .
  • Seasonality and U.S. mix: Expect Q2 volume pickup with potential declines in Q3–Q4; shifts in payer mix (e.g., Medicare Part D) and rebates influence net price dynamics .

Estimates Context

  • Revenue missed S&P Global consensus ($42.0M actual vs. $50.7M*), reflecting U.S. generics and RoW shipment timing; Europe grew sequentially but remains small base .
  • EPS beat S&P Global consensus (actual $(0.04) vs. $(0.77)*) due to improved gross margin and disciplined OpEx, despite revenue pressure .
  • With only two estimates contributing for Q1 2025, coverage remains thin; expect models to recalibrate for RoW revenue variability and Europe’s gradual ramp (Italy/Austria benefits) .

Values retrieved from S&P Global for estimate metrics marked with *.

Key Takeaways for Investors

  • Europe is the near‑term growth lever: sequential demand +16% and expanding access (Italy, Austria) support scaling through 2025; monitor Norway/Ireland decisions as incremental catalysts .
  • U.S. remains cash‑generative despite generics; expect seasonality and payer mix/rebate pressure to continue—AG launch optionality provides a tactical hedge on lifecycle value .
  • RoW contribution will be lumpy near term as partners manage launch stocking vs. demand; China NRDL (target 2026) and Australia guideline inclusion underpin medium‑term upside .
  • Balance sheet strength ($281.8M cash/investments; no debt) and regained Nasdaq compliance reduce structural risk and support continued execution in EU/RoW .
  • Expect estimate revisions: revenue likely marked down on Q1 miss with partial offset from stronger margins and OpEx control; watch for upward revisions tied to European access milestones .
  • Non‑GAAP loss narrowed vs. Q4; continued margin mix improvements and OpEx discipline are key to sustaining EPS outperformance relative to low expectations .
  • Near‑term trading: catalysts include EU reimbursement decisions, evidence/policy endorsements, and any AG decision; risks center on U.S. pricing dynamics and RoW timing variability .

Values retrieved from S&P Global for estimate metrics marked with *.